Breast CancerNCT01527409
The Efficacy of Health Partnership Program for Cancer Patients
A study testing Tailored health partnership program in people with Breast Cancer and Colon Cancer, run by National Cancer Center, Korea at 10 sites in South Korea.
Trial summary
The Objectives of this study is 1. To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of participating in tailored program (Health Partnership Program) for 24 weeks 2. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Colon Cancer, Gastric Cancer
- What is being tested?
- Tailored health partnership program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Feb 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult(≥ 20 years)
- Within 24 months of completion of primary treatment with curative intent (Surgery, radiotherapy, chemotherapy)
- Breast, cervical, colorectal (except rectal cancer), lung, and stomach cancer
- More than two problematic areas among exercise, diet (Fruit \& Vegetable: F\&V), and posttraumatic growth(exercise < 150min/week, ≥ 3mets, F\&V < 5/day, PTGI < 71)
Who cannot join
- Evidence of secondary tumor, metastasis and recurrence
- Patients undergoing or planning surgery, radiation therapy or chemotherapy
- Not Korean speaking and reading (Not communication with Korean)
- Not understanding of the study purpose and not written informed consent
- Participants who have an similar study experience
- Major health problem in which exercise/nutrition intervention is contraindicated at the discretion of clinician; cardiovascular disease (congestive heart failure, angina), pulmonary disease (chronic obstructive pulmonary disease, restrictive pulmonary disease), uncontrolled hypertension, poorly controlled diabetes and severe musculoskeletal disease and so on
Show all 14Show fewer
- Sign of infection (body temperature ≥ 37.2℃ or WBC ≥ 11,000)
- Being pregnant
- Thrombocytopenia (platelet count ≤ 100,000/mcl)
- Anemia (Hb ≤ 10g/dL)
- SGOT or SGPT > 40 IU/L
- Creatinine > 1.2 mg/dL
- Severe psychiatric disorder (psychotic disorder, major depression and so on) or suicidal tendencies
- dyspnea
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Recruiting
Seoul National University Boondang Hospital
Boondang, Gyunggi
Jae Young Lim, PhD
Jae Young Lim, PhD
- Recruiting
Keimyng University Dongsan Center
Daegu
Chiheum Cho, PhD
Chiheum Cho, PhD
- Recruiting
National Cancer Center
Goyang, Gyunggi
Youngsung Lee, PhD, lee.medric@gmail.com
Youngsung Lee, PhD
- Recruiting
Asan Medical Center
Seoul
KyungHae Jung, PhD
KyungHae Jung, PhD
- Recruiting
Ewha Womans University Mokdong Hospital
Seoul
Soon Nam Lee, PhD
Soon Nam Lee, PhD
- Recruiting
Korea University Anam Hospital
Seoul
Eun Sook Lee, PhD
Eun Sook Lee, PhD
- Recruiting
KyungHee University Medical Center
Seoul
Siyoung Kim, PhD
Siyoung Kim, PhD
- Recruiting
Samsung Medical Center
Seoul
Sung Kim, PhD
Sung Kim, PhD
- Recruiting
Seoul National University Hospital
Seoul
Young Ho Yun, PhD, lawyun08@gmail.com
Dong Young Noh, PhD
- Recruiting
Ajou University Medical Center
Suwon, Gyunggi
Mi Sun Chun, PhD
Mi Sun Chun, PhD
About this study
The Objectives of this study is
- To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of participating in tailored program (Health Partnership Program) for 24 weeks
- To evaluate the efficacy for quality of life, life satisfaction, health leadership, anxiety, depression, impact of event, social support, cancer belief as a result of participating in tailored program (Health Partnership Program) for 24 weeks
- To assess the efficacy of such intervention compared with usual care in cancer patients
Read the detailed description
***Background
Improving cancer patients' quality of life has been increasing subject of research for several years. Especially, the patients and their families who are needed to deal with specific care on diverse aspects, such as social, spiritual, existential, psychological aspect should be provided integrated program.
Multidimensional characteristics of the health partnership program were addressed in National Cancer Center (NCC) for exercise, diet, and posttraumatic growth based on transtheoretical (TTM) model, social cognitive theory, health behavioral model, and coaching strategies. This program points out the importance of behavioral approaches in managing their healthy life according to improve patterns of three areas (exercise, diet, and posttraumatic growth).
Strategies that investigators mentioned above can lead those three areas to be effective.
To objective of this study is to support cancer patients to cope with exercise, diet, and posttraumatic growth through tailored program (the health partnership program), and then evaluate the efficacy of the health partnership program.
From evidence extracted from a literature review, contents of the program was elaborated, and tailored from the TTM model. The curriculum is currently being reviewed and validated by expert group of oncologists, nurse, psychologist and health education scientists.
***Method
To determine the efficacy of the program (the health partnership program), a randomized controlled trial will be conducted:
After excluding patients with other causes (anemia, thyroid disease, co morbidities etc), 248 patients will be recruited based on statistical assumption of alpha (0.05), beta (0.20=power 80%), and dropout rate (15%).
First, patients will be stratified according to their age, sex (male vs. female), cancer types (stomach cancer, Breast cancer, cervical cancer, colorectal (except rectal cancer) cancer, and lung cancer), and then allocated to an intervention or control group.
When intervention group participates in the tailored program (the health partnership program), they can receive various information which is related to health management and improving quality of life.
The health partnership program consists of 16 time's tele-coaching, a self leadership workshop, and providing health materials (manuals, workbook, and booklet). Especially, those will be dealt with managing three areas; exercise, diet, and posttraumatic growth based on the transtheoretical model (TTM), social cognitive theory, health behavioral model, and coaching strategies.
Cancer patients who are participated in the tailored program will be received tailored feedbacks that enhance participants of the next level of the program.
On the other hand, the control group could not participate in the health partnership program. The control group could only be treated by usual care and a health education workshop with a health booklet. However, the control group can participate in the health partnership program after 12 month.
Data will be collected before randomization, after intervention, and after a follow-up of 3, 6, and 12 months.
- Conditions
- Breast Cancer, Colon Cancer, Gastric Cancer, Lung Cancer
- Being tested
- Tailored health partnership program, Usual care and health education workshop
- Keywords
- Exercise, Diet, Posttraumatic growth
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Stomach Neoplasms, Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored health partnership programBehavioural
When intervention group participate in the tailored program, they can receive various information which is related with three strategic areas (exercise, diet, and posttraumatic growth).
Three areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model.
Patients will be received tailored manual and workbook for health tele-coaching that help them to lead their healthy life.
The health tele-coaching will be operated sixteen times for 24 weeks. Intervention group will be provided three contents (exercise, diet, and posttraumatic growth) from health partners. The health partners took a certificate that is related with health, leadership and coaching.
Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life. It will be proceeded for four hours. Three hours is for the leadership, and the last one hour is for presentation of their health mission statement.
Usual care and health education workshopBehavioural
While intervention group participate in the tailored health partnership program, control group can receive various information which is related with ten contents for health management (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation). They will be provided a workshop and booklet for a health education for four hours.
Twelve month later, they will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth as same as the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Experimetal Arm | Experimental | Providing tailored health care program, which provides various information related to exercise, diet, and posttraumatic growth.
Tailored health partnership program consists of three strategic areas (exercise, diet, and posttraumatic growth). Those areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model.
Patients who participate in the tailored health partnership program will be received tailored manual and workbook for tele-coaching that help them to lead their healthy life.
Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life. Receives: Behavioral: Tailored health partnership program |
| Control Arm | No intervention | Providing usual care. Also, patients will be provided a workshop for health education that is dealt with ten areas (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation).
Twelve month later, patients will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth. Receives: Behavioral: Usual care and health education workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI)
How much the patient does exercise will be measured using "MET" score. Change in diet will be observed by analyzing 3day recall.
Measured: baseline, 3month, 6month, and 12month
Secondary outcomes (7)
Seven habit profile
Measured: baseline, 3month, 6month, and 12month
the European Organisation for the Research and Treatment of Cancer Quality-of-life Questionnaire-Core 30(EORTC QLQ C-30)
Measured: baseline, after 3month, 6month, and 12month
Ed Diner's Satisfaction with Life Scale
Measured: baseline, after 3month, 6month, and 12month
Impact of Event Scale-Revised
Measured: baseline, after 3month, 6month, and 12month
Social Support(MOS-SSS)
Measured: baseline, after 3month, 6month, and 12month
the Hospital Anxiety and Depression scale(HADS)
Measured: baseline, after 3month, 6month, and 12month
Cancer Belief System(CBS)
Measured: baseline, after 3month, 6month, and 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Samsung Medical Center, Seoul National University Hospital, Korea University Anam Hospital, Asan Medical Center, Ajou University School of Medicine, Kyunghee University Medical Center
- Responsible party
- Principal investigator, YoungSung Lee, National Cancer Center, Korea
- Investigators
- YoungSung Lee, MD, Ph.D, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527409
- Sponsor's protocol ID
- NCCCTS-11-598
- Status last verified
- Feb 2012
- First submitted
- 10 Jan 2012
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Eun Sook Lee, M. K. L., Soo Hyun Kim, Jung Sil Ro, Han Sung Kang, Seok Won Kim, Keun Seok Lee, Young Ho Yun. (2010(Accepted) ).
Kravitz, R. L., D. J. Tancredi, et al. (2009).
Park, S. M., M. K. Lim, et al. (2007).
Shin, H. W., D. Y. Noh, et al. (2009).
Soo Hyun Kim, M. S. S., Han Sul Lee, Eun Sook Lee, Jung Sil Ro, Han Sung Kang, Seok Won Kim, Won Hee Lee, Chun Ja Kim, Hee Soon Kim, Joo hyung Kim, Young Ho Yun (2010).
Street, R. L., Jr., C. Slee, et al.
Vale, M. J., M. V. Jelinek, et al. (2003).
Wolever, R. Q., M. Dreusicke, et al.
Demark-Wahnefried W, Clipp EC, Lipkus IM, Lobach D, Snyder DC, Sloane R, Peterson B, Macri JM, Rock CL, McBride CM, Kraus WE. Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors. J Clin Oncol. 2007 Jul 1;25(19):2709-18. doi: 10.1200/JCO.2007.10.7094.
PubMed 17602076Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
PubMed 21190455Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
PubMed 19436015Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4.
PubMed 22263004Kim SH, Shin MS, Lee HS, Lee ES, Ro JS, Kang HS, Kim SW, Lee WH, Kim HS, Kim CJ, Kim J, Yun YH. Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. Oncol Nurs Forum. 2011 Mar;38(2):E97-106. doi: 10.1188/11.ONF.E97-E106.
PubMed 21356647Yun YH, Kim YA, Lee MK, Sim JA, Nam BH, Kim S, Lee ES, Noh DY, Lim JY, Kim S, Kim SY, Cho CH, Jung KH, Chun M, Lee SN, Park KH, Park S. A randomized controlled trial of physical activity, dietary habit, and distress management with the Leadership and Coaching for Health (LEACH) program for disease-free cancer survivors. BMC Cancer. 2017 May 2;17(1):298. doi: 10.1186/s12885-017-3290-9.
PubMed 28464804
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Health Partnership Program for Cancer Patients
- ClinicalTrials.gov ID
- NCT01527409
- Acronym / sponsor ID
- NCCCTS-11-598
- Conditions
- Breast Cancer, Colon Cancer, Gastric Cancer, Lung Cancer
- Keywords
- Exercise, Diet, Posttraumatic growth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Samsung Medical Center, Seoul National University Hospital, Korea University Anam Hospital, Asan Medical Center, Ajou University School of Medicine, Kyunghee University Medical Center
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 7 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Objectives of this study is
- To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of participating in tailored program (Health Partnership Program) for 24 weeks
- To evaluate the efficacy for quality of life, life satisfaction, health leadership, anxiety, depression, impact of event, social support, cancer belief as a result of participating in tailored program (Health Partnership Program) for 24 weeks
- To assess the efficacy of such intervention compared with usual care in cancer patients
Detailed description
***Background
Improving cancer patients' quality of life has been increasing subject of research for several years. Especially, the patients and their families who are needed to deal with specific care on diverse aspects, such as social, spiritual, existential, psychological aspect should be provided integrated program.
Multidimensional characteristics of the health partnership program were addressed in National Cancer Center (NCC) for exercise, diet, and posttraumatic growth based on transtheoretical (TTM) model, social cognitive theory, health behavioral model, and coaching strategies. This program points out the importance of behavioral approaches in managing their healthy life according to improve patterns of three areas (exercise, diet, and posttraumatic growth).
Strategies that investigators mentioned above can lead those three areas to be effective.
To objective of this study is to support cancer patients to cope with exercise, diet, and posttraumatic growth through tailored program (the health partnership program), and then evaluate the efficacy of the health partnership program.
From evidence extracted from a literature review, contents of the program was elaborated, and tailored from the TTM model. The curriculum is currently being reviewed and validated by expert group of oncologists, nurse, psychologist and health education scientists.
***Method
To determine the efficacy of the program (the health partnership program), a randomized controlled trial will be conducted:
After excluding patients with other causes (anemia, thyroid disease, co morbidities etc), 248 patients will be recruited based on statistical assumption of alpha (0.05), beta (0.20=power 80%), and dropout rate (15%).
First, patients will be stratified according to their age, sex (male vs. female), cancer types (stomach cancer, Breast cancer, cervical cancer, colorectal (except rectal cancer) cancer, and lung cancer), and then allocated to an intervention or control group.
When intervention group participates in the tailored program (the health partnership program), they can receive various information which is related to health management and improving quality of life.
The health partnership program consists of 16 time's tele-coaching, a self leadership workshop, and providing health materials (manuals, workbook, and booklet). Especially, those will be dealt with managing three areas; exercise, diet, and posttraumatic growth based on the transtheoretical model (TTM), social cognitive theory, health behavioral model, and coaching strategies.
Cancer patients who are participated in the tailored program will be received tailored feedbacks that enhance participants of the next level of the program.
On the other hand, the control group could not participate in the health partnership program. The control group could only be treated by usual care and a health education workshop with a health booklet. However, the control group can participate in the health partnership program after 12 month.
Data will be collected before randomization, after intervention, and after a follow-up of 3, 6, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimetal Arm | Experimental | Behavioral: Tailored health partnership programProviding tailored health care program, which provides various information related to exercise, diet, and posttraumatic growth. Tailored health partnership program consists of three strategic areas (exercise, diet, and posttraumatic growth). Those areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model. Patients who participate in the tailored health partnership program will be received tailored manual and workbook for tele-coaching that help them to lead their healthy life. Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life. |
| Control Arm | No intervention | Behavioral: Usual care and health education workshopProviding usual care. Also, patients will be provided a workshop for health education that is dealt with ten areas (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation). Twelve month later, patients will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult(≥ 20 years)
- Within 24 months of completion of primary treatment with curative intent (Surgery, radiotherapy, chemotherapy)
- Breast, cervical, colorectal (except rectal cancer), lung, and stomach cancer
- More than two problematic areas among exercise, diet (Fruit \& Vegetable: F\&V), and posttraumatic growth(exercise < 150min/week, ≥ 3mets, F\&V < 5/day, PTGI < 71)
Key exclusion criteria (14 listed)
- Evidence of secondary tumor, metastasis and recurrence
- Patients undergoing or planning surgery, radiation therapy or chemotherapy
- Not Korean speaking and reading (Not communication with Korean)
- Not understanding of the study purpose and not written informed consent
- Participants who have an similar study experience
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored health partnership programWhen intervention group participate in the tailored program, they can receive various information which is related with three strategic areas (exercise, diet, and posttraumatic growth). Three areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model. Patients will be received tailored manual and workbook for health tele-coaching that help them to lead their healthy life. The health tele-coaching will be operated sixteen times for 24 weeks. Intervention group will be provided three contents (exercise, diet, and posttraumatic growth) from health partners. The health partners took a certificate that is related with health, leadership and coaching. Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life. It will be proceeded for four hours. Three hours is for the leadership, and the last one hour is for presentation of their health mission statement. | Behavioural | Experimetal Arm |
| Usual care and health education workshopWhile intervention group participate in the tailored health partnership program, control group can receive various information which is related with ten contents for health management (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation). They will be provided a workshop and booklet for a health education for four hours. Twelve month later, they will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth as same as the intervention group. | Behavioural | Control Arm |
Primary outcome
Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI)
Time frame: baseline, 3month, 6month, and 12month
How much the patient does exercise will be measured using "MET" score. Change in diet will be observed by analyzing 3day recall.
7 secondary outcomes
Seven habit profile
Time frame: baseline, 3month, 6month, and 12month
the European Organisation for the Research and Treatment of Cancer Quality-of-life Questionnaire-Core 30(EORTC QLQ C-30)
Time frame: baseline, after 3month, 6month, and 12month
Ed Diner's Satisfaction with Life Scale
Time frame: baseline, after 3month, 6month, and 12month
Impact of Event Scale-Revised
Time frame: baseline, after 3month, 6month, and 12month
Social Support(MOS-SSS)
Time frame: baseline, after 3month, 6month, and 12month
the Hospital Anxiety and Depression scale(HADS)
Time frame: baseline, after 3month, 6month, and 12month
Cancer Belief System(CBS)
Time frame: baseline, after 3month, 6month, and 12month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
- BackgroundEun Sook Lee, M. K. L., Soo Hyun Kim, Jung Sil Ro, Han Sung Kang, Seok Won Kim, Keun Seok Lee, Young Ho Yun. (2010(Accepted) ).
- BackgroundKravitz, R. L., D. J. Tancredi, et al. (2009).
- BackgroundPark, S. M., M. K. Lim, et al. (2007).
- BackgroundShin, H. W., D. Y. Noh, et al. (2009).
- BackgroundSoo Hyun Kim, M. S. S., Han Sul Lee, Eun Sook Lee, Jung Sil Ro, Han Sung Kang, Seok Won Kim, Won Hee Lee, Chun Ja Kim, Hee Soon Kim, Joo hyung Kim, Young Ho Yun (2010).
- BackgroundStreet, R. L., Jr., C. Slee, et al.
- BackgroundVale, M. J., M. V. Jelinek, et al. (2003).
- BackgroundWolever, R. Q., M. Dreusicke, et al.
- Background: PubMed 17602076Demark-Wahnefried W, Clipp EC, Lipkus IM, Lobach D, Snyder DC, Sloane R, Peterson B, Macri JM, Rock CL, McBride CM, Kraus WE. Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors. J Clin Oncol. 2007 Jul 1;25(19):2709-18. doi: 10.1200/JCO.2007.10.7094.
- Background: PubMed 21190455Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
- Background: PubMed 19436015Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
- Background: PubMed 22263004Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YoungSung Lee, MD, Ph.D principal investigator
National Cancer Center, Korea
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored health partnership program in people with Breast Cancer and Colon Cancer, run by National Cancer Center, Korea at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YoungSung Lee, Ph.D (+82-31-920-2010, lee.medric@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI) (time frame: baseline, 3month, 6month, and 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01527409, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2012.